(171 days)
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
The Contour I is comprised of multiple components, including the control unit and ultrasonic transducer. The Contour I V3.1 selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the Contour I achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
Here's a breakdown of the acceptance criteria and study details for the Syneron Contour I V3.1 System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Threshold) | Reported Device Performance (Mean) | Statistical Significance (P-Value) |
|---|---|---|---|
| Abdominal Circumference Reduction | > -1.5 cm | -2.0 cm | 0.0464 |
| (Difference between Control and Device Phases) | (compared to -1.5 cm) |
Note: The acceptance criteria is inferred from the statement: "The primary effectiveness endpoint measured the difference between the change in circumference for device and control phases...relative to the protocol-specified clinically meaningful threshold of -1.5 cm." The reported device performance ("average circumference reduction of -2.0 cm") significantly exceeded this threshold, indicating a positive outcome.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Primary Endpoint (ITT population): n=109 (subjects in Group 1 who completed both control and device phases)
- Safety Population: 150 subjects (118 in Group 1, 32 in Group 2)
- Data Provenance: The study was a "multicenter, randomized, controlled study." The origin country is not specified, but the device submitter is from Israel. The study was prospective in nature, involving active treatment and follow-up.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth in this study was objective quantitative measurement (abdominal circumference reduction) rather than expert interpretation of images or clinical findings.
- Number of Experts: Not applicable in the traditional sense of image interpretation.
- Qualifications of Experts: It is stated that the "individual measuring the subject's abdominal circumference was not the same person who treated the subject, and was blinded to the subject's treatment group." This implies trained personnel, but specific qualifications (e.g., years of experience in performing circumference measurements) are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 typically apply to the resolution of conflicting expert opinions for ground truth establishment. Since the primary endpoint was an objective measurement, an adjudication method in this sense is not applicable. The blinding of the assessor to the treatment group served to minimize bias in the measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance on diagnostic tasks. The Contour I System is a therapeutic device for aesthetic body contouring; its effectiveness is measured by direct physical changes (circumference reduction), not by a diagnostic reading task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The study describes the performance of the device (Contour I V3.1 System) in performing subcutaneous adipose tissue disruption. This can be considered a "standalone" evaluation of the device's therapeutic effect, as it directly acts on the tissue. There isn't an "algorithm" in the sense of a diagnostic AI, but the device's mechanical and acoustic properties are what achieve the therapeutic effect. The clinical trial directly assesses this effect.
7. The Type of Ground Truth Used
The ground truth used was objective quantitative measurement of change in abdominal circumference. This is an outcomes-based measurement directly reflecting the device's intended therapeutic effect.
8. The Sample Size for the Training Set
The document does not explicitly describe a separate "training set" in the context of machine learning. The clinical study described is an evaluation study of the device's safety and effectiveness in humans.
- However, the document mentions "In vivo and ex vivo testing in the animal model was performed. In addition, ex vivo testing on the Contour I family of devices demonstrated the treatment effects of the Contour I, and supported its safety and efficacy profile for the intended use." These non-clinical studies could be considered forms of "training" or development data used to optimize the device's parameters before human trials, but a specific sample size for such a "training set" for an algorithm is not provided as the device is not an AI diagnostic tool.
9. How the Ground Truth for the Training Set Was Established
As there is no explicitly defined "training set" for an AI algorithm in the document, the establishment of ground truth for a training set (in the machine learning sense) is not applicable.
However, for the non-clinical studies (animal and ex vivo) mentioned, the "ground truth" would have been established through direct observation of treatment effects on tissue, histological analysis, and physical/acoustic measurements.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.